Q3 ICH Guidelines for Impurities
Q3 ICH Guidelines for Impurities: Q3A (R2): Impurities in New Drug Substances: First recommended for adoption at Step 4 of the ICH Process on 30 March 1995, the guideline was revised under Step …
Guidelines
The guidelines section keeps you up to date with respect to the current published guidelines of the pharmaceutical industry.
ICH Guideline: Q2 Analytical Validation
Q2 Analytical Validation: The guideline Q2 analytical validation identifies validation parameters that are needed for various analytical methods. Here are two revisions of the Q2 analytical validation guideline; Q2(R1): Validation …
ICH stability Guidelines Q1A – Q1F
ICH stability Guidelines Q1A to Q1F: This Guidelines have been developed by the appropriate ICH Expert Working Group and have been subject to consultation by the regulatory parties, in accordance …
Q1A (R2) Stability ICH guideline purpose of revision
Before understanding the purpose for the revision of stability ICH guidelines need to understand what ICH stands for. What is ICH Full form? ICH stands for “International Council for Harmonization …
Clinical Trials In Human Medicines as per EU
Clinical Trials In Human Medicines as per EU: For its opinions on the approval of medicines, the European Medicines Agency (EMA) relies on the results of clinical trials carried out …
What is ICH Q10 in the Pharmaceutical Quality System?
In this article, we are going to learn about Scope of ICH Q10 and Objective of ICH Q10 in pharmaceutical. ICH Q10 In Pharmaceutical Quality System In 2008, ICH Q10 …
50 Electronic Codes of Federal Regulation (e-CFR) in pharma
As per FDA there are 50 title of Electronic Codes Of Federal Regulation (E-CFR) In Pharmaceutical. In this article we will see the all 50 title of electronic code of …
Important Difference between 21 CFR part 11 and EU Annex 11
21 CFR part 11 and EU annex 11 both are guidance for the electronic records and electronic signature. The guidances are applied to the computerized systems that used to store …
Understand 14 ICH guidelines in the pharmaceutical in an easy way
ICH full form: International Council on Harmonisation of a technical requirement for registration of pharmaceutical for human use. ICH is a joint initiative of three different regulatory bodies (USA, Europe, and Japan) as …
